Cats and dogs:
• Treatment and prevention of flea infestations caused by Ctenocephalides spp. for one month following a single administration. This is as a result of the adulticidal, larvicidal and ovicidal properties of the product. The product is ovicidal for 3 weeks after administration. Through a reduction in the flea population, monthly treatment of pregnant and lactating animals will also aid in the prevention of flea infestations in the litter up to seven week of age. The product can be used as part of a treatment strategy for flea allergy dermatitis and through its ovicidal and 3 larvicidal action may aid in the control of existing environmental flea infestations in area to which the animal has access.
• Prevention of heartworm disease caused by Dirofilaria immitis with monthly administration. The product may be safely administered to animals infected with adult heartworms, however, it is recommended, in accordance with good veterinary practice, that all animals 6 months of age or more living in countries where a vector exists should be tested for existing adult heartworm infections before beginning medication with the product. It is also recommended that dogs should be tested periodically for adult heartworm infections, as an integral part of a heartworm prevention strategy, even when the product has been administered monthly. This product is not effective against adult D. immitis.
• Treatment of ear mites (Otodectes cynotis).
Cats:
• Treatment of biting lice infestations (Felicola subrostratus)
• Treatment of adult roundworms (Toxocara cati)
• Treatment of adult intestinal hookworms (Ancylostoma tubaeforme).
Dogs:
• Treatment of biting lice infestations (Trichodectes canis)
• Treatment of sarcoptic mange (caused by Sarcoptes scabiei)
• Treatment of adult intestinal roundworms (Toxocara canis).
Contraindications
Do not use in animals under 6 weeks of age.
Do not use in cats that are suffering from concomitant disease, or are debilitated and underweight (for size and age).
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
Special warnings for each target species
Animals may be bathed 2 hours after treatment without loss of efficacy.
Do not apply when the animal's hair coat is wet. However, shampooing or soaking the animal 2 or more hours after treatment will not reduce the efficacy of the product.
For ear mite treatment, do not apply directly in the ear canal.
Special precautions for use
Special precautions for use in animals
This veterinary medicinal product is to be applied to the skin surface only. Do not administer orally or parenterally.
Keep treated animals away from fires and other sources of ignition for at least 30 minutes or until the hair coat is dry.
It is important to apply the dose as indicated to minimise the quantity that the animal can lick off. If significant licking does occur, a brief period of hypersalivation may rarely be observed in cats.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
This product is highly flammable; keep away from heat, sparks, open flames or other sources of ignition. Do not smoke, eat or drink while handling the product.
This product is a skin and eye irritant.Wash hands after use and wash off any product in contact with the skin immediately with soap and water. If accidental eye exposure occurs, flush the eyes immediately with water and seek medical advice immediately and show the package leaflet or the label to the physician.
Avoid direct contact with treated animals until the application site is dry. On the day of treatment, children must not handle treated animals and the animals should not be permitted to sleep with their owners, especially children. Used applicators should be disposed of immediately and not left within the sight or reach of children.
People with sensitive skin or known allergy to veterinary medicinal product of this type should handle the product with caution.
Other precautions
Do not allow treated animals to bathe in water courses until at least two hours after treatment administration.
Adverse reactions (frequency and seriousness)
Mild transient alopecia at the site of application has been reported rarely after use of the veterinary medicinal product in cats. Transient focal irritation may also be observed very rarely. The alopecia and irritation are normally self-resolving, but symptomatic therapy may be applicable in some circumstances.
Local temporary clumping of the hair at the application site and/or an occasional appearance of a small quantity of a white powder has been reported rarely. This is normal and will disappear typically within 24 hours of treatment administration and does not affect either the safety or efficacy of the veterinary medicinal product. If significant licking does occur, a brief period of hypersalivation may rarely be observed in cats.
As with other macrocyclic lactones, reversible neurological signs, including seizures, have been very rarely observed after use of the veterinary medicinal product in both dogs and cats.
Use during pregnancy, lactation or lay
The product can be used in breeding, pregnant and lactating cats and dogs.
Interaction with other medicinal products and other forms of interaction
None known
